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A Study of Probiotics in IBS Subjects

Sponsor
Vedic Lifesciences Pvt. Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03482765
Collaborator
(none)
336
Enrollment
12
Locations
3
Arms
15
Actual Duration (Months)
28
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For the current study, the primary outcome is to evaluate the effect of IP on abdominal pain.

The secondary outcome is to assess the effect of IP on IBS-Symptom Severity, IBS-related quality of life, stool form and consistency and on mental status.

Thus providing an effective objective in improving the gut health and symptomatic relief in IBS patients.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic 1
  • Dietary Supplement: Probiotic 2
  • Other: Placebo
 N/A

Detailed Description

This study aims to determine the effect of probiotics, as the investigational products (IPs) in subjects satisfying the Rome IV criteria for IBS. Three hundred and sixty six subjects between 18 to 70 years of age and with a positive diagnosis of Rome IV IBS criteria (IBS-C, D, M and U types) and moderate to severe abdominal pain intensity will be recruited in a multi-center, double-blind, parallel group, placebo-controlled randomized trial.

Study Design

Study Type:
Interventional
Actual Enrollment :
336 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Apart from the participant and Investigator, the study team is also blinded.
Primary Purpose:
Supportive Care
Official Title:
A Double-blind Randomized, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Probiotics (UABla-12™ and DDS®-1) on Digestive Health in IBS Subjects
Actual Study Start Date :
Mar 30, 2018
Actual Primary Completion Date :
Mar 14, 2019
Actual Study Completion Date :
Jun 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotic 1

Probiotic 1: A dietary probiotic supplement which contains Bifidobacterium lactis. Dose: > 10 billion CFU, Frequency: 1 capsule/day, duration: 6 weeks.

Dietary Supplement: Probiotic 1
The product under investigation is a unique probiotic.
Other Names:
  • Bifidobacterium lactis

    		•
    Experimental: Probiotic 2

    Probiotic 2: A dietary probiotic supplement which contains Lactobacillus acidophilus. Dose: > 10 billion CFU, Frequency: 1 capsule/day, duration: 6 weeks.

    Dietary Supplement: Probiotic 2
    The product under investigation is a unique probiotic.
    Other Names:
  • Lactobacillus acidophilus

    		•
    Placebo Comparator: Placebo

    The Placebo contains MCC.

    Other: Placebo
    Microcrystalline Cellulose

    Outcome Measures

    Primary Outcome Measures

    1. Change in abdominal pain severity [42 days]

      The change at Day 42 will be assessed by subject dairy.

    Secondary Outcome Measures

    1. Change in abdominal pain severity [Day 21]

      The change at Day 21 will be assessed by subject dairy

    2. Change in IBS symptoms [Day 42]

      The change at Day 42 will be compared to baseline

    3. Change in stool consistency [Day 42]

      The change at Day 42 will be compared to baseline by specific questionnaire

    4. Change in Quality of Life [Day 42]

      The change at Day 42 will be compared to baseline by specific questionnaire

    5. Change in daily number of stools [Day 42]

      The change at Day 42 will be compared to baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Literate (as defined by the basic capability to read and understand in the languages approved for the study), male and female subjects in age range of 18-70 years.

    • Presence of Rome IV diagnostic criteria for IBS.

    Exclusion Criteria:

    • Anemic subjects with Hb < 10 g/dl.

    • Subjects with organic disease (to be ruled out by physician based on prior history and physical examination).

    • Subjects with a history of surgical resection of the stomach, small intestine or large intestine.

    • Subjects with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis.

    • Subjects with complications from infectious enteritis, hyperthyroidism or hypothyroidism.

    • Subjects with a history of any diet-based intolerance (gluten or lactose intolerance).

    • Subjects with a history of drug or alcohol abuse within the past 6 months.

    • Subjects with a history of or complications from malignant tumors.

    • Subjects with severe depression or an anxiety disorder, which could potentially affect the efficacy evaluation (as determined by the qualified investigator).

    • Subjects with uncontrolled hypertension (≥140/90 mm Hg).

    • Subjects with complications from serious cardiovascular diseases, respiratory diseases, endocrinological and gynecological disorder, renal diseases, hepatic diseases, gastrointestinal diseases (excluding IBS), blood diseases or neurological or psychiatric diseases.

    • Subjects who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.

    • Subjects with a history of dysmenorrhea.

    • Subjects with any unstable medical conditions.

    • Subjects with uncontrolled Type II diabetes mellitus.

    • Subjects with a history of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable.

    • Subjects who are immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis).

    • Subjects with any medical condition or a history of abdominal surgery that is deemed exclusionary by the qualified investigator.

    • Subjects with an active eating disorder.

    • Subjects who have used an over-the-counter or prescription laxative medication or any other herbal agents affecting GI motility within 2 weeks prior to screening.

    • Subjects who have used probiotic or fiber supplements (or probiotic/fiber enriched foods) or an antibiotic within 4 weeks prior to screening.

    • Subjects who have used IBS specific treatments within 4 weeks prior to screening.

    • Subjects who currently consume greater than 2 standard alcoholic drinks per day from past 3 months.

    • Subjects who smoke ≥ 1 cigarette per day. Occasional (Non-daily) smokers will be allowed.

    • Subjects who have participated in a clinical research trial within 30 days prior to randomization.

    • Subjects with an allergy or sensitivity to the probiotic products.

    • Subjects who are cognitively impaired and/or who are unable to give an informed consent.

    • Subjects who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the qualified investigator, may adversely affect the subjects' ability to complete the study or its measures or which may pose significant risk to the subject.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Apex Gastro Clinic Ahmedabad Gujrat India 380013
    2 Gastrocare & Liver Clinic Ahmedabad Gujrat India 380015
    3 The Gut Clinic Mumbai Maharashtra India 400012
    4 Vazifdar Clinic Mumbai Maharashtra India 400055
    5 Stress Test Clinic Mumbai Maharashtra India 400059
    6 Shantaee Nursing Home Mumbai Maharashtra India 400067
    7 Dr Sanjeev Khanna's Clinic Mumbai Maharashtra India 400069
    8 Ameeta Nursing home Mumbai Maharashtra India 400071
    9 Lancelot Kidney and GI Center Mumbai Maharashtra India 400092
    10 Kshirsagar Nursing Home Mumbai Maharashtra India 400602
    11 Samarth Clinic Navi Mumbai Maharashtra India 400703
    12 Sampada Hospital Thāne Maharashtra India 400601

    Sponsors and Collaborators

    • Vedic Lifesciences Pvt. Ltd.

    Investigators

    • Study Director: Shalini Srivastava, M.D., Vedic Lifesciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vedic Lifesciences Pvt. Ltd.
    ClinicalTrials.gov Identifier:
    NCT03482765
    Other Study ID Numbers:
    • UAS/170901/PB/IBS
    First Posted:
    Mar 29, 2018
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 5, 2019